The technology and biology behind OASIS® Matrix is well studied as a successful wound management approach

SIS matrix research includes

>1300

studies1

>375

clinical human studies1

20

clinical wound publications to date1

Mostow Study

Greater efficacy achieved with OASIS Wound Matrix + standard care* vs standard care* alone in the treatment of chronic leg ulcers13

  • 55% of OASIS Wound Matrix group patients achieved full wound epithelialization at 12 weeks vs 34% in the control group (P=0.0196)
  • 100% of patients in the OASIS Wound Matrix maintained wound closure at six months
55% of patients treated with OASIS Wound Matrix plus standard care achieved full wound epithelialization versus 34% of patients treated with standard care alone.

*Standard of care in both treatment groups consisted of SOC which included wound cleansing, sharp debridement (as clinically necessary at the discretion of the investigator), dressing changes, and compression therapy.

Results are statistically significant

Study overview, endpoints, and design

Mostow EN, et al. (2005)
Objective To compare the effectiveness of small intestine submucosa (SIS) wound matrix with standard care* vs standard care* alone in healing chronic leg ulcers within 12 weeks
Primary endpoint Evaluating the proportion of ulcers healed in each group at 12 weeks, defined as full epithelialization of the wound with the absence of drainage
Limitations
  • Study was not blinded
  • Establishment of venous disease before enrollment was not always confirmed with duplex imaging
Patient demographics

120 patients with at least 1 chronic leg ulcer

OASIS Matrix + standard care* group; n=62

  • Age: 63 ± 2
  • Female: 53% | Male: 47%
  • Ethnicity: White 82% | Black 16% | Asian 0% | Other 2%
  • Mean ulcer area: 10.2 ± 1.51cm2

Standard care* group; n=58

  • Age: 65 ±2
  • Female: 64% | Male: 36%
  • Ethnicity: White 79% | Black 16% | Asian 2% | Other 3%
  • Mean ulcer area: 12.1 ± 1.98cm2
Design
(prospective, randomized, controlled, multicenter study)

12-week clinical study:

12 weeks of treatment, follow-up at 6 months


Two arms:

OASIS Matrix + standard care* group; n=62


Standard care* group; n=58

*Standard care in both groups was an ALLEVYN non-adherent dressing followed by a PROFORE four-layer compression bandaging system.

Cazzell Study

Greater efficacy achieved with OASIS ULTRA Tri-Layer Matrix vs standard care in the treatment of diabetic foot ulcers (DFUs)14

  • Wounds treated with OASIS ULTRA Tri-Layer Matrix reached closure 69% more often than wounds treated with standard care alone by Week 12 (P=0.021)
  • Wounds treated by OASIS ULTRA Tri-Layer Matrix reached closure at a median of 2 weeks earlier than those that closed in the standard care group
  • OASIS ULTRA Tri-Layer Matrix had a greater reduction in wound area vs standard care in as little as 1 week (P=0.017)
  • OASIS ULTRA Tri-Layer Matrix sustained improvements in DFUs with a 43% greater reduction in wound area vs standard care at Week 12 (P=0.05)
Study showed a 69% relative increase in ulcers achieving complete wound closure from baseline at 12 weeks for wounds treated with OASIS ULTRA Tri-Layer Matrix vs wounds treated with standard care alone.

Study overview, endpoints, and design

Cazzell SM, et al. (2015)
Objective To demonstrate that superior outcomes are possible when DFUs are managed with tri-layer porcine small intestine submucosa (SIS)
Primary endpoint Evaluating the proportion of subjects with complete ulcer closure over the 12-week treatment period. Ulcer closure was defined as 100% re-epithelialization, no drainage, and no need for a dressing.
Secondary endpoints
  • Time in days to complete ulcer closure over the treatment period
  • Percent change in ulcer area from baseline for each visit
  • Proportion of subjects with complete ulcer closure at each visit
  • Durability of closure/additional new closures at 16-week follow-up visit
Limitations Study was not blinded
Patient demographics

82 patients with a diabetic foot ulcer

OASIS ULTRA group; n=41

  • Age: 57.1 (range 23-85)
  • Female: 22% | Male: 78%
  • Ethnicity: Hispanic/Latino: 24% | Non-Hispanic/Latino: 76%
  • Mean wound area: 2.1cm2

Standard care group; n=41

  • Age: 56.6 (range 34-80)
  • Female: 27% | Male: 73%
  • Ethnicity: Hispanic/Latino: 39% | Non-Hispanic/Latino: 61%
  • Mean wound area: 2.6cm2
Design (Randomized, parallel group, open-label, multicenter study)

16-week clinical study:

12 weeks of treatment, 4 weeks of follow-up

Two arms:

OASIS ULTRA group; n=41

Standard care group; n=41

Standard care was selected by the investigator and included debridement of necrotic tissue, infection control, off-loading, and maintenance of a moist wound environment.